FDA 510(k) Application Details - K122784

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K122784
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	BIONESS, INC. 25103 RYE CANYON LOOP VALENCIA, CA 91355 US Other 510(k) Applications for this Company
Contact	KIM TOMPKINS Other 510(k) Applications for this Contact
Regulation Number	882.5810   More FDA Info for this Regulation Number
Classification Product Code	GZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/11/2012
Decision Date	12/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review